The clinical evaluation of medical devices refers to the process in which the registered applicant confirms whether the product meets the requirements for use or the scope of application through clinical literature, clinical experience data, clinical trials and other information.
Companies are required to conduct the clinical trials for the higher risk medical devices in China. They are divided into clinical trial and clinical verification depending on whether the risk can be controlled. The regulations on medical device and clinical trial in China have been revised and implemented from 1st Jun 2014. It may be involve long time, great effort and resources to develop the clinical trials in China.
In general, there are five main methods for clinical evaluation of medical devices in China. That is:
- In the catalog of medical devices exempted from clinical trials (need to submit a comparison with a similar product registered in China)
- Analytical evaluation by data obtained from clinical trials or clinical application of medical devices of the same variety
- Adopt overseas clinical trial data
- Adopt real-world data
- Clinical trials
Which medical device is required to conduct clinical trial in China?
Class II and class III medical devices are required to develop clinical trial in China according to the “Regulations for the Supervision and Administration of Medical Devices”, only the devices designated by NMPA to be exempted from clinical trial are not required to conduct the clinical trial, but the clinical evaluation report should be submitted.
Overseas Clinical Trial Data
The research data generated in the process of confirming the safety and effectiveness of medical devices to be registered in China under normal use conditions in clinical trial institutions with the requirements of the country (region) where the clinical trial is conducted.
Overseas clinical trials need to comply with the relevant regulations of overseas clinical trials and are carried out in countries (regions) with clinical trial quality management and also meet the regulatory requirements for clinical trials of medical devices (including in vitro diagnostic reagents) in China.
The overseas clinical trial materials submitted by the applicant shall include at least: clinical trial protocol, ethical opinions, and clinical trial report. The clinical trial report should include analysis and conclusions of the complete clinical trial data.